Blood pump

ABSTRACT

An intravascular blood pump comprises a pump casing having a blood flow inlet and a blood flow outlet, and an impeller arranged in said pump casing so as to be rotatable about an axis of rotation, wherein the impeller has blades sized and shaped for conveying blood from the blood flow inlet to the blood flow outlet. The blood pump further comprises a drive unit for rotating the impeller, the drive unit comprising a plurality of posts arranged about the axis of rotation, wherein each of the posts includes a shaft portion and a head portion. Coil windings around the posts are sequentially controllable so as to create a rotating magnetic field. The drive unit further comprises a back plate which engages ends of the shaft portions of the posts opposite the head portions.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 16/087,546 (now U.S. Pat. No. 11,097,092), filed Sep. 21, 2018,which is a national phase entry under 35 U.S.C. § 371 of InternationalApplication No. PCT/EP2017/056613, filed Mar. 21, 2017, published asInternational Publication No. WO 2017/162619 A1, which claims priorityfrom European Patent Application No. 16161941.6, filed on Mar. 23, 2016,the disclosures of which are hereby incorporated herein by reference.

This invention relates to a blood pump, in particular an intravascularblood pump for percutaneous insertion into a patient's blood vessel, tosupport a blood flow in a patient's blood vessel. The blood pump has animproved drive unit which allows for reduction of the outer diameter ofthe blood pump.

Blood pumps of different types are known, such as axial blood pumps,centrifugal blood pumps or mixed-type blood pumps, where the blood flowis caused by both axial and radial forces. Intravascular blood pumps areinserted into a patient's vessel such as the aorta by means of acatheter. A blood pump typically comprises a pump casing having a bloodflow inlet and a blood flow outlet connected by a passage. In order tocause a blood flow along the passage from the blood flow inlet to theblood flow outlet, an impeller or rotor is rotatably supported withinthe pump casing, with the impeller being provided with blades forconveying blood.

Blood pumps are typically driven by a drive unit, which can be anelectric motor. For instance, US 2011/0238172 A1 disclosesextracorporeal blood pumps having an impeller which may be magneticallycoupled to an electric motor. The impeller comprises magnets which aredisposed adjacent to magnets in the electric motor. Due to attractingforces between the magnets in the impeller and in the motor, rotation ofthe motor is transmitted to the impeller. In order to reduce the numberof rotating parts, it is also known from US 2011/0238172 A1 to utilize arotating magnetic field, with the drive unit having a plurality ofstatic posts arranged about the axis of rotation, and each post carryinga wire coil winding and acting as a magnetic core. A control unitsequentially supplies a voltage to the coil windings to create therotating magnetic field. In order to provide a sufficiently strongmagnetic coupling, the magnetic forces have to be high enough, which canbe achieved by a sufficiently high current supplied to the drive unit orby providing large magnets, which, however, leads to a large overalldiameter of the blood pump.

SUMMARY OF THE INVENTION

It is therefore an object of the present invention to provide a bloodpump, preferably an intravascular blood pump or transvalvular bloodpump, having a magnetic coupling between the drive unit and theimpeller, wherein the blood pump has a compact design, in particular asufficiently small outer diameter to allow the blood pump to be insertedtransvascularly, transvenously, transarterially or transvalvularly.

This object is achieved according to the present invention by a bloodpump having the features of independent claim 1. Preferred embodimentsand further developments of the invention are specified in the claimsdependent thereon.

According to the invention, the blood pump, which preferably is anintravascular blood plump and may be one of an axial blood pump, acentrifugal blood pump and a mixed-type blood pump, comprises a driveunit for rotating the impeller. The drive unit comprises a plurality ofposts, such as at least two, at least three, at least four, at leastfive or preferably six posts, that are arranged about the axis ofrotation. Higher numbers of posts, such as eight, ten or twelve, may bepossible. The number of posts is preferably even for a balanced controlof the impeller, but it may also be odd, such as three or five. Each ofthe posts includes a shaft portion and a head portion, with the headportion pointing towards the impeller. In order to create a rotatingmagnetic field, a coil winding is disposed about the shaft portion ofeach of the posts, with the coil windings being sequentiallycontrollable so as to create the rotating magnetic field. The impellercomprises at least one magnet, which is arranged to magnetically couplethe impeller to the drive unit, i.e., to interact with the rotatingmagnetic field so as to cause rotation of the impeller.

A drive unit that creates a rotating electromagnetic field allows forsimplification of the mechanics of the blood pump by reducing the numberof moving parts compared to a common electric motor. This also reduceswear, because no contact bearing for an electric motor is necessary. Themagnetic coupling between the drive unit and the impeller not onlycauses rotation of the impeller but also permits correct alignment ofthe impeller. In particular, the magnetic coupling may provide an axialas well as a radial bearing.

In order to increase the density of the magnetic coupling between thedrive unit and the magnets of the impeller, it may be advantageous toactivate several posts simultaneously, where “activate” means to supplyelectric power to the respective coil winding in order to create arespective pole magnet. For example, more than half of the posts may beactivated at the same time, such as four of six posts, depending on thenumber of posts and number of magnets in the impeller. Preferably, thearrangement of activated and inactivated posts is rotationallysymmetrical and the posts are controlled in pairs.

The drive unit further comprises a back plate which engages ends of theshaft portions of the plurality of posts that are opposite to the headportions. In one embodiment, the back plate may comprise a plurality ofapertures arranged about the axis of rotation for receiving said ends ofthe shaft portions, preferably at a regular angular distance. However,it will be appreciated that the post can be attached, connected orsecured to the back plate by other means, either permanently orreleasably. The back plate particularly serves for closing the magneticflux circuit to facilitate and increase the magnetic flux generation andimprove the coupling capability. Since the magnetic flux is increased bythe back plate, the overall diameter of the blood pump can be reduced,which is particularly advantageous for intravascular blood pumps. Thearrangement including the posts with the back plate further allows forhigh frequencies of the blood pump, i.e., the blood pump can operate ata high speed. In addition, as the back plate engages the posts, the backplate provides structural stability for the post assembly.

The back plate may be made of magnetic steel or other material suitablefor closing the magnetic flux circuit, preferably cobalt steel. Thediameter of the back plate may be about 3 mm to 9 mm, such as 5 mm or 6mm to 7 mm. The thickness of the back plate may be about 0.5 mm to about2.5 mm, such as 1.5 mm. The outer diameter of the blood pump may be fromabout 4 mm to about 10 mm, preferably about 6 mm. The outer diameter ofthe arrangement of the plurality of posts, in particular the largestouter diameter of the arrangement of the plurality of posts which ismeasured at the head portions of the posts may be about 3 mm to 8 mm,such as 4 mm to 6 mm, preferably 5 mm.

The dimensions of the posts, in particular length and cross-sectionalarea, may vary and depend on various factors. In contrast to thedimensions of the blood pump, e.g., the outer diameter, which depend onthe application of the blood pump, the dimensions of the posts aredetermined by electromagnetic properties, which are adjusted to achievea desired performance of the drive unit. One of the factors is the fluxdensity to be achieved through the smallest cross-sectional area of theposts. The smaller the cross-sectional area, the higher is the necessarycurrent to achieve the desired magnetic flux. A higher current, however,generates more heat in the wire of the coil due to electricalresistance. That means, although “thin” posts are preferred to reducethe overall size, this would require high current and, thus, result inundesired heat. The heat generated in the wire also depends on thelength and diameter of the wire used for the coil windings. A short wirelength and a large wire diameter are preferred in order to minimize thewinding loss (referred to as “copper loss” or “copper power loss” ifcopper wires are used, which is usually the case). In other words, ifthe wire diameter is small, more heat is generated compared to a thickerwire at the same current, a preferred wire diameter being e.g., 0.05 mmto 0.2 mm, such as 0.1 mm. Further factors influencing the postdimensions and the performance of the drive unit are the number ofwindings of the coil and the outer diameter of the windings, i.e., thepost including the windings. A large number of windings may be arrangedin more than one layer around each post, for instance, two or threelayers may be provided. However, the higher the number of layers, themore heat will be generated due to the increased length of the wire inthe outer layers having a larger winding diameter. The increased lengthof the wire may generate more heat due to the higher resistance of along wire compared to a shorter one. Thus, a single layer of windingswith a small winding diameter would be preferred.

A typical number of windings, which in turn depends on the length of thepost, may be about 50 to about 150, e.g., 56 or 132.

In one embodiment, the impeller may also comprise a yoke or back platethat is attached to the at least one magnet of the impeller, preferablyat a side of the impeller facing away from the drive unit, e.g., betweenthe magnet and blades of the impeller. Like the back plate that isattached to the ends of the shafts of the posts, the yoke or back plateof the impeller serves for closing the magnetic flux circuit to increasethe magnetic flux generation and enhance the coupling capability. It maybe made of magnetic steel, preferably cobalt steel.

The posts may be made of magnetic steel, too. Preferably, the driveunit, including the posts and the back plate, is made of cobalt steel.The use of the cobalt steel contributes to reducing the pump size, inparticular the diameter. With the highest magnetic permeability andhighest magnetic saturation flux density among all magnetic steels,cobalt steel produces the most magnetic flux for the same amount ofmaterial used.

It may be further advantageous for the efficiency and performance of thedrive unit if the posts are magnetically insulated against each other.Thus, a magnetically insulating material may be disposed between thehead portions of adjacent posts so as to separate the posts from eachother and keep the respective magnetic field within the respective post.The magnetically insulating material may be a magnetic material, themagnetic field of which keeps the electromagnetic field caused by thecoil windings within the respective post. At least, an air gap or otherinsulating, i.e., electrically non-conductive, material may be providedbetween the head portions of the posts to avoid a short-circuit betweenthe posts.

In one embodiment, the head portion of at least one of the posts,preferably of each of the posts, has a top surface that is inclined atan angle relative to a plane perpendicular to the axis of rotation. Adistance between the axis of rotation and a center in a radial directionof said inclined surface may be less than or equal to a distance betweenthe axis of rotation and a center in a radial direction of across-sectional area of the shaft portion of the respective post. Thecenter in a radial direction of a surface or area is the center betweena radially innermost point and a radially outermost point of the surfaceor area. In other words, the inclined top surface of the head portion,which is the surface facing the impeller, may extend obliquely or may beinclined at an angle relative to the axis of rotation, and half or moreof the inclined surface may be located radially inwards relative to thecenter of the shaft portion. This enables the outer diameter of thedrive unit and, thus, of the blood pump, to be kept at a minimum that isnecessary for magnetically coupling the drive unit to the impeller. Thisreduced diameter design is particularly advantageous for intravascularblood pumps that are located within a patient's blood vessel during pumpoperation and can be deployed by means of a catheter. In addition, theinclined coupling surface provides for radial centering of the impeller.The aforementioned angle is preferably 45°, but may be between about 0°and about 90°, preferably between about 30° and about 60°, morepreferably between about 40° to about 50°, with respect to a planeperpendicular to the axis of rotation. The inclined surfaces of theposts preferably face radially outwards, i.e., they form a convex shape.Alternatively, the inclined surfaces may face radially inwards to form aconcave shape.

All of the posts preferably are identical such that the drive unit issymmetrical with respect to the axis of rotation. It will beappreciated, however, that the posts do not have to be exactly identicalas long as they are compatible for forming the drive unit according tothe invention. However, it is preferable for shaft portions to have thesame length and the inclined surfaces of the head portions to have thesame angle of inclination. Different posts may be irregularly orregularly arranged to form the drive unit, such as in an alternatingmanner.

The inclined surface of the head portion of said at least one post,preferably of each of the head portions, may be radially aligned with orbe located radially inwards or outwards with respect to a radiallyoutermost surface of the coil winding of the respective post. Theinclined surface preferably extends radially inwards beyond therespective shaft portion towards the axis of rotation so as to maximizethe surface area of the magnetic bearing, while minimizing the outerdiameter of the drive unit. For instance, in an axial projection, i.e.,as seen in a top view in an axial direction, the inclined surface of thehead portion may be located within the coil winding or may be at leastaligned with the shaft or coil winding in an axial direction. In anotherembodiment, the head portion may extend beyond the outer circumferenceof the coil winding in a radial and/or circumferential direction. Thehead portion may have a larger cross-sectional dimension than therespective shaft portion in a plane perpendicular to the axis ofrotation, with the respective coil winding preferably not extendingbeyond the head portion at least in a radial direction. In other words,the head portion may form a shoulder, which can act as an axial stop forthe coil winding as well as a radial limitation.

At least one of the head portions, preferably all head portions, may besubstantially triangular or trapezoidal in cross-section along a planeincluding the axis of rotation. In the assembled state, the oblique orinclined surfaces of the head portions may together form a conicalsurface or substantially conical surface, e.g., a surface having facetsbut forming approximately a conical surface. Generally, the shape of theformed surface can be convex. Illustratively speaking, the head portionsmay be put together like pie slices to form a circular arrangementhaving a conical top surface. The at least one magnet of the impellermay have or may form a conical or substantially conical recesssubstantially corresponding in size and shape to the conical surfaceformed by the head portions of the posts. Generally, the magnet may forma concave surface facing the convex surface formed by the posts toimprove the magnetic coupling. In another embodiment, the arrangement ofconcave and convex surfaces may be vice versa, i.e., the head portionsof the posts may form a conical recess while the magnet forms a convexconical surface.

The respective convex and concave surfaces of the drive unit and theimpeller respectively may form a gap such that the distance between thesurfaces is constant. Preferably, however, the gap distance is notconstant but is chosen such that the cross-sectional area of the gap,viewed in a circumferential direction, is constant in a radialdirection. In the latter case the distance between the surfacesincreases towards the axis of rotation. Combinations may also beenvisioned. The shape and dimension of the gap between the impeller andthe drive unit may contribute to hydrodynamic bearing capabilities.

The magnet of the impeller may be formed as a single piece having theconical or substantially conical recess that corresponds to the shape ofthe head portions of the posts, including a gap with varying distance asexplained above. It will be appreciated, however, that there may beprovided a plurality of magnets, such as two or more, e.g., four,preferably six magnets, or even eight, ten or twelve magnets, that arearranged in the impeller about the axis of rotation and form the conicalrecess. Providing a plurality of magnets, preferably an even number,more preferably a number corresponding to the number of posts, isadvantageous because the magnets can be arranged with alternatingnorth/south orientations of the magnetic field without dead zones. Ifthe magnet is provided as a single piece, dead zones may be created atthe transitions between differently oriented magnetic fields.

If the impeller includes a plurality of magnets, the magnets may bearranged with substantially no gaps between the individual magnets inorder to increase the amount of magnetic material. However, it has beenfound that the efficiency of the magnetic coupling does not decrease ifthe magnets are separated by gaps, in particular radially extendinggaps. This is because of the characteristics of the magnetic field andthe gap between the drive unit and the impeller. If the magnets in theimpeller are close to each other, the innermost magnetic field lines,which extend in an arch from one magnet (north) to an adjacent magnet(south), do not extend beyond the gap between the drive unit and theimpeller and, thus, do not reach the drive unit, i.e., they do notcontribute to the drive of the impeller. Therefore, there is no loss inefficiency if a gap is provided between the magnets in the impeller. Thesize of gap between the magnets in the impeller that can be providedwithout loss of efficiency of the drive is dependent on the size of thegap between the impeller and the drive unit as a skilled person cancalculate. The gaps between the impeller magnets can then be used e.g.,as wash out channels.

Generally speaking, and regardless of whether the head portions form aconical surface, the magnet of the impeller may have a surface thatfaces the head portions of the posts and is inclined at an anglesubstantially corresponding to the angle of the inclined surfaces of thehead portions. For instance, the arrangement may be the converse of theaforementioned arrangement, that is to say, the head portions of theposts may form a concave surface, such as a conical recess, and themagnet of the impeller may form a convex surface, such as a conicalsurface.

Regardless of the inclination of the respective surfaces, the magnet ormagnets of the impeller may be radially aligned with the head portionsof the posts. However, in some embodiments, the magnet or magnets of theimpeller may be radially offset with respect to the head portions of theposts, such as radially inwards or radially outwards. This radial offsetmay improve stabilizing and radial centering of the impeller because themagnetic forces between the impeller and the drive unit have a radialcomponent, whereas the magnetic forces are directed merely substantiallyaxially if the magnets are radially aligned with the head portion of theposts.

In one embodiment, the impeller may extend at least partially about thedrive unit, in particular the head portions of the posts. In otherwords, the impeller may have an extension that overlaps the drive unitin a circumferential direction. That means the magnetic coupling takesplace not only in the region of the inclined surfaces of the headportions of the posts but also on radially outer side surfaces thereof.The impeller may have an increased diameter, in particular a largerdiameter than the drive unit, such that the impeller can extend aboutthe area of the head portions of the posts. The impeller may, thus, havea recess that has a conical portion as described above and a cylindricalportion. The magnetic coupling can be improved by this design of theimpeller because the impeller and the drive unit are coupled in a radialdirection as well, where the magnetic field lines extend in a radialdirection. In this area a high torque can be created to drive theimpeller due to the largest diameter.

In one embodiment, the intravascular blood pump may further comprise ahousing surrounding the drive unit, with the housing preferablycorresponding in size and shape to an outer contour of the plurality ofposts. In particular, the housing may have a conical axial end surfacecorresponding to the shape of the surface formed by the inclinedsurfaces of the posts' head portions. The opposite end may be open andmay engage the back plate to close the housing. The housing serves as aprotection for the post assembly, particularly as a protection againstblood contact, which is particularly useful for the coil windings.Preferably, the housing is disposed inside the pump casing. Regardlessof the presence of such housing, the drive unit preferably is arrangedinside the pump casing. The housing is preferably made of a non-magneticand non-conductive (i.e., electrically insulating) material and providesgood heat transfer. The material of the housing may be e.g., aluminum.

The coil windings may be embedded in a thermally conductive matrix,which is electrically non-conductive (i.e., electrically insulting). Thematrix protects the coil windings and transfers heat produced by thecoil windings. The material of the thermally conductive matrix maybe aplastics material with additives in order to increase the thermallyconductive characteristics. For instance, the matrix may comprise anepoxy resin with aluminum additives. The matrix may be formed by moldingthe material around and between the coil windings and subsequentlycuring the material.

Preferably, the drive unit has a central opening that extends along theaxis of rotation. The central opening may be formed by the head portionsof the posts and may be configured for receiving an elongate pin, withan axial end surface of the pin being sized and dimensioned to form abearing surface for the impeller. This arrangement allows for a compactdesign of the blood pump because the space between the posts is used forthe pin. The other end of the pin may be supported by the pump casing.The central opening may also be provided for insertion of a guide wireor the like or may form a fluid path.

In order to enhance a wash-out flow through the gap between the impellerand the drive unit, a secondary set of blades may be provided in theimpeller. In particular, secondary blades may be provided on the side ofthe magnet or magnets that faces the drive unit, i.e., in the gapbetween the impeller and the drive unit. The wash-out flow mayadditionally or alternatively be increased by channels that are recessedin the surface of the magnet that faces the drive unit. The channels mayextend e.g., radially or helically.

In one embodiment, one or more hydrodynamic bearings may be provided tosupport the impeller. For instance, the aforementioned secondary bladesand the channels may form a hydrodynamic bearing or at least supporthydrodynamic bearing capabilities as mentioned above with respect to thesize and shape of the gap between the impeller and the drive unit.Conversely, the surface of the drive unit that faces the impeller, i.e.,in particular the end surface of the housing that encloses the driveunit, may be adapted to form a hydrodynamic bearing. The hydrodynamicbearing may be axial or radial or both axial and radial. In particularbecause of the conical shape of the interface between the impeller andthe drive unit, a hydrodynamic bearing in both radial and axialdirections can be formed. A radial hydrodynamic bearing may also beformed between an outer surface of the impeller and an inner surface ofthe pump casing. In particular, a gap may be formed between the impellerand the pump casing, where an amount of blood sufficient for thehydrodynamic bearing flows through the gap and exits the pump casingthrough an additional blood flow outlet. The main blood flow exits thepump casing through the blood flow outlet and does not flow through thegap. Hydrodynamic bearings, which are contactless bearings, may supportthe function of the drive unit by reducing frictional forces.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing summary, as well as the following detailed description ofpreferred embodiments, will be better understood when read inconjunction with the appended drawings. For the purpose of illustratingthe present disclosure, reference is made to the drawings. The scope ofthe disclosure is not limited, however, to the specific embodimentsdisclosed in the drawings. In the drawings:

FIG. 1 shows a cross-sectional view of a blood pump according to theinvention.

FIG. 2 shows an enlarged detail of the blood pump of FIG. 1 .

FIG. 3 shows a perspective view of a post of a drive unit.

FIGS. 4 a-4 d show different views of another embodiment of a post,where FIG. 4 a shows a cross-sectional view of the post along line A-Ain FIG. 4 d , FIG. 4 b shows a side view of the post, FIG. 4 c shows abottom view of the post, and FIG. 4 d shows a top view of the post.

FIG. 5 shows an arrangement including six posts.

FIG. 6 shows the arrangement of FIG. 5 along with a back plate.

FIG. 7 shows the arrangement of FIG. 6 along with coil windings.

FIG. 8 shows the arrangement of FIG. 7 along with a housing.

FIGS. 9 a-9 c show different views of a back plate, where FIG. 9 a showsa top view of the back plate, FIG. 9 b shows a cross-sectional view ofthe back plate along line A-A in FIG. 9 a , and FIG. 9 c shows across-sectional view of the back plate along line B-B in FIG. 9 a.

FIGS. 10 a-10 c show different views of the magnets of the impeller,where FIG. 10 a shows a top view of the magnets, FIG. 10 b shows a sidecross-sectional view of the magnets along line A-A in FIG. 10 a , andFIG. 10 c shows a perspective view of the magnets.

FIG. 11 shows another embodiment of a drive unit.

FIG. 12 shows another embodiment of a blood pump.

FIGS. 13 a and 13 b show different views of a drive unit and impellermagnets according to another embodiment.

FIGS. 14 a and 14 b schematically illustrate magnetic field linesbetween magnets of the impeller.

FIG. 15 shows a cross-sectional view of a drive unit and impellermagnets according to another embodiment.

FIG. 16 schematically illustrates an operating mode of the drive unit.

DETAILED DESCRIPTION

Referring to FIG. 1 , a cross-sectional view of a blood pump 1 isillustrated. FIG. 2 shows an enlarged view of the interior of the bloodpump 1. The blood pump 1 comprises a pump casing 2 with a blood flowinlet 21 and a blood flow outlet 22. The blood pump 1 is designed as anintravascular pump, also called a catheter pump, and is deployed into apatient's blood vessel by means of a catheter 25. The blood flow inlet21 is at the end of a flexible cannula 23 which may be placed through aheart valve, such as the aortic valve, during use. The blood flow outlet22 is located in a side surface of the pump casing 2 and may be placedin a heart vessel, such as the aorta. The blood pump 1 is connected tothe catheter 25, with an electric line 26 extending through the catheter25 for supplying the blood pump 1 with electric power in order to drivethe pump 1 by means of a drive unit 4, as explained in more detailbelow.

The blood is conveyed along a passage 24 connecting the blood flow inlet21 and the blood flow outlet 22 (blood flow indicated by arrows). Animpeller 3 is provided for conveying blood along the passage 24 and ismounted to be rotatable about an axis of rotation 10 within the pumpcasing 2 by means of a first bearing 11 and a second bearing 12. Theaxis of rotation 10 is preferably the longitudinal axis of the impeller3. Both bearings 11, 12 are contact-type bearings in this embodiment. Atleast one of the bearings 11, 12 could be a non-contact-type bearing,however, such as a magnetic or hydrodynamic bearing. The first bearing11 is a pivot bearing having spherical bearing surfaces that allow forrotational movement as well as pivoting movement to some degree. A pin15 is provided, forming one of the bearing surfaces. The second bearing12 is disposed in a supporting member 13 to stabilize the rotation ofthe impeller 3, the supporting member 13 having at least one opening 14for the blood flow. Blades 31 are provided on the impeller 3 forconveying blood once the impeller 3 rotates. Rotation of the impeller 3is caused by a drive unit 4 magnetically coupled to a magnet 32 at anend portion of the impeller 3. The illustrated blood pump 1 is amixed-type blood pump, with the major direction of flow being axial. Itwill be appreciated that the blood pump 1 could also be a purely axialblood pump, depending on the arrangement of the impeller 3, inparticular the blades 31.

FIG. 2 illustrates in more detail the interior of the blood pump 1, inparticular the impeller 3 and the drive unit 4. The drive unit 4comprises a plurality of posts 40, such as six posts 40, only two ofwhich are visible in the cross-sectional view of FIG. 2 . The posts 40have a shaft portion 41 and a head portion 42. The head portion 42 isdisposed adjacent to the impeller 3 in order to magnetically couple thedrive unit 4 to the impeller 3. For this purpose, the impeller 3 has amagnet 32, which is formed as a multiple piece magnet in this embodimentas described in more detail with reference to FIGS. 10 a-c . The magnet32 is disposed at the end of the impeller 3 facing the drive unit 4. Theposts 40 are sequentially controlled by a control unit (not shown) inorder to create a rotating magnetic field for driving the blood pump 1.The magnet 32 is arranged to interact with the rotating magnetic fieldso as to cause rotation of the impeller 3 about the axis of rotation 10.Coil windings are arranged about the shaft portions 41 of the posts 40,as described in more detail below with reference to FIG. 7 .

In order to close the magnetic flux path, a back plate 50 is located atthe end of the shaft portions 41 opposite the head portions 42. Theposts 40 act as a magnetic core and are made of a suitable material,such as steel or a suitable alloy, in particular cobalt steel. Likewise,the back plate 50 is made of a suitable magnetic material, such ascobalt steel. The back plate 50 enhances the magnetic flux, which allowsfor reduction of the overall diameter of the blood pump 1, which isimportant for intravascular blood pumps. For the same purpose, a yoke37, i.e., an additional back plate, is provided in the impeller 3 at aside of the magnet 32 facing away from the drive unit 4. The yoke 37 inthis embodiment has a conical shape in order to guide the blood flowalong the impeller 3. The yoke 37 may be made of cobalt steel, too. Oneor more wash-out channels that extend towards the central bearing may beformed in the yoke 37 or the magnet 32.

Details of the drive unit 4 are shown in FIGS. 3 to 9 , while FIG. 10illustrates the magnet 32 of the impeller 3. Referring to FIG. 3 , oneof the posts 40 is shown in a perspective view. In this embodiment, allof the posts 40 in the assembly (i.e., six posts 40) are identical. Thepost 40 includes a shaft portion 41 and a head portion 42. The headportion 42 has an inclined surface 43, angled at 60° with respect to thelongitudinal axis in this embodiment (i.e., 30° with respect to a planeperpendicular to the longitudinal axis). The shaft portion 41 includesan end portion 44 opposite the head portion 42, having a reduceddiameter for engaging the back plate 50. The head portion 42 has alarger cross-sectional dimension than the shaft portion 41 in a planeperpendicular to the longitudinal axis. The head portion 42 has sidesurfaces 47 that are adjacent to the side surfaces of an adjacent postwhen assembled to form the drive unit 4. In order to avoid ashort-circuit of the magnetic flux between the posts 40, a small air gapor other type of insulation is provided between the head portions 42.Further to avoiding a short-circuit, it may be advantageous to providean insulation material between the head portions 42 of the posts 40 thatkeeps the magnetic field within each of the posts 40. In other words,the head portions 42 may be separated by a magnetically insulatingmaterial. For instance, magnets, e.g., plates of a magnetic material,can be arranged between the head portions 42 to separate the headportions 42 and the respective magnetic fields from each other. Radiallyinner surfaces 48 of the post head portions 42 form a central opening54. It will be appreciated that the transition surface between thesurfaces 43 and 48 does not need to be rounded.

Different views of another embodiment of a post 40 are shown in FIG. 4 ,which corresponds to the previous embodiment except for slight changesin the shape of the shaft portion 41 and the head portion 42. FIG. 4 ashows a cross-sectional view along the line A-A illustrated in FIG. 4 d, which shows a top view (i.e., towards the head portion 42) of the post40. FIG. 4 b shows a perspective view of the post 40, while FIG. 4 cshows a bottom view (i.e., a view towards the end portion 44 of theshaft portion 41). The post 40 may have an overall length of about 9 to10 mm, wherein the head portion 42 may have a length of about 2 mm. Inthis embodiment, the head portion 42 has a surface 43 which is inclinedat an angle of 45° with respect to the axis of rotation or longitudinalaxis. Accordingly, the angle 45 between the surface 43 and a ledge 49shown in FIG. 4 a is 135°. The ledge 49 may serve as a stop when theposts 40 are assembled in a housing. Furthermore, a shoulder 46 isformed by the head portion 42, which may serve as a stop for a coilwinding. As described in connection with FIG. 3 , the head portion 42comprises side surfaces 47 and a radial inner surface 48.

FIG. 5 illustrates an assembly including six posts 40, described inconnection with FIG. 3 . All posts 40 are formed identically, such thateach head portion 42 forms a 60° segment of a circle, that is to say, a“pie slice” of 60°. It will be appreciated that the assembly may includefewer or more posts, such as two, three, four or five or more than six,where the angle depends on the number of posts, e.g., four posts thateach form a 90° segment or eight posts that each form a 45° segment. Asalready mentioned above, the number of posts 40 is preferably even,where diametrically opposed posts 40 may form a pair, e.g., with respectto control of the magnetic field, i.e., each pair of posts may becontrolled as a unit to activate the posts of each respective pairsimultaneously. The head portions 42 form a cone having a conicalsurface formed by the inclined surfaces 43. This can be seen moreclearly in FIG. 6 . In FIG. 6 , the reduced-diameter end portions 44 ofthe shaft portions 41 are mounted in the back plate 50.

In FIG. 7 the same arrangement is illustrated including coil windings 47about the posts 40. The coil windings 47 do not extend radially beyondthe head portions 42, thereby providing for a compact outer dimension.It will be appreciated that preferably the maximum cross-sectional areadefined by the head portions 42 is used for the coil windings 47 tooptimize usage of the available space and to minimize air gaps that actas an insulator and affect the magnetic flux. Further, the diameter ofthe shaft portions 41 of the posts 40 is chosen so as to optimize thenumber of windings of the coil windings 47. FIG. 8 shows a housing 60which is to be mounted over the post arrangement. The housing 60conforms to the shape of the post arrangement and comprises asubstantially cylindrical portion 62 and a conical end portion 61. Theconical end portion 61 is tapered at the same angle as the conicalsurface formed by the inclined surfaces 43 of the posts' head portions42, that is to say, the angle preferably is between about 30° to 60°,preferably 30° or 45°, with respect to a plane perpendicular to thelongitudinal axis. The housing 60 is closed by the back plate 50 at anopen end 63 opposite the conical end portion 61. The conical end portion61 has a central opening 64 that is aligned with the central opening 54formed by the posts 40 and a central opening 53 in the back plate 50.

The back plate 50 is illustrated in more detail in different views inFIG. 9 (top view in FIG. 9 a , cross-sectional view along line A-A inFIG. 9 b , and cross-sectional view along line B-B in FIG. 9 c ). Theback plate 50 has apertures 51 for receiving the reduced-diameter endportions 44 of the shaft portions 41 of the posts 40. Preferably, thenumber of apertures 51 in the back plate 50 corresponds to the number ofposts 40 of the drive unit 4. In the embodiment shown, six apertures 51are disposed at a regular distance of 60° about the axis of rotation 10,with each of the apertures 51 being at the same distance from the axisof rotation 10. The apertures 51 are shown as extending completelythrough the back plate 50 in the cross-sectional view of FIG. 9 c .However, the apertures 51 may alternatively extend into the back plate50 only up to a certain depth rather than completely through the backplate 50. A central opening 53 is formed for receiving the bearing pin15, as described above. The back plate 50 is made of a magneticmaterial, preferably cobalt steel, to close the magnetic flux path. Thediameter of the back plate 50 may be about 5 to 7 mm. Furthermore,notches 52 are provided at the periphery of the back plate 50 forreceiving wires 56 to connect the coil windings 47 to a control unit 55,such as a printed circuit board (PCB) at the back of the back plate 50,as shown schematically by dashed lines in FIG. 9 b.

Referring to FIG. 10 , the magnet 32 of the impeller 3 (see FIG. 2 ) isshown in a top view (FIG. 10 a ), a cross-sectional view (FIG. 10 b )and a perspective view (FIG. 10 c ). In this embodiment, six magnets 32are provided that are arranged uniformly about the axis of rotation 10,with the orientation of the respective magnetic field alternating. Feweror more magnets, such as four, eight, ten or twelve magnets, may beprovided. The magnets 32 form a recess 35 having a surface 33. Therecess 35 corresponds in size and shape to the conical surface formed bythe surfaces 43 of the head portions 42 of the posts 40, as shown bestin FIG. 6 , taking into account the housing 60 that surrounds the driveunit 4, in particular the conical end portion 61 (FIG. 8 ). It will beappreciated that this includes that the distance between the impeller 3and the drive unit 4 may not be constant but may increase towards theaxis of rotation 10 as explained above. The recess 35 in this embodimenthas a conical shape with an angle 34 of 45° with respect to the axis ofrotation 10 or longitudinal axis. Other angles, such as 60°, arepossible, depending on the shape of the drive unit 4, in particular theend surface formed by the head portions 42 of the posts 40. Furthermore,the magnets 32 form a central opening 36 for receiving the bearing pin15, as shown in FIG. 2 . The central opening 36 is aligned to thecentral opening 54 of the drive unit 4. As shown in FIG. 10 b , themagnetic flux of the magnets 32 is closed by the yoke 37. The yoke 37may have any suitable shape depending on the shape of the impeller 3,such as conical as shown in FIG. 2 or disc-shaped as indicated in FIG.10 b . Optionally, an encapsulation 38 is provided that encloses themagnets 32 and, if applicable, the yoke 37 to protect the magnets 32 andyoke 37 against corrosion.

In FIG. 11 is illustrated another embodiment of a drive unit which issubstantially similar to the aforementioned embodiments. The arrangementincludes six posts 40′ having a respective coil winding 47 on theirshaft portions 41′. As in the previous embodiments, there may be feweror more posts 40′. The posts 40′ are preferably attached to a back plate(not shown) as in the previous embodiments. The posts 40 each include ahead portion 42′, which has a different shape from the above-describedhead portions 42. Although the angle may be the same as described above,the inclined surfaces 43′ face radially inwards rather than radiallyoutwards. That is to say, the head portions 42′ form a substantiallyconical recess. It will be appreciated that the magnet of the impellerwill be shaped accordingly, i.e., the magnet will have a correspondingconical shape rather than a conical recess as in the previousembodiments. As in the previous embodiments, the drive unit has acentral opening 54′. The posts 40′ in the embodiment of FIG. 11 areseparated by gaps 57′ that prevent a bypass or short-circuit between theposts 40′, whereas the head portions 42 of the posts 40 in the previousembodiments are shown to be directly adjacent to each other or separatedonly by small gaps. It will be appreciated, however, that ashort-circuit between the posts is to be avoided in all embodiments.

With reference to FIG. 12 , another embodiment of a blood pump 1 isshown, which is similar to that of FIGS. 1 and 2 . In contrast to theabove embodiment, the blood pump 1 of FIG. 12 has an additional radialhydrodynamic bearing. A circumferential portion 28 of the pump casing 2or sleeve is provided to form a gap 27 between the impeller 3 and thecircumferential portion 28. In addition to the blood flow outlet 22 afurther blood flow outlet 29 allows blood to flow through the gap 27 andout of the pump casing 2. The size of the gap 27 is chosen so as to forma radial hydrodynamic bearing.

FIGS. 13 a and 13 b schematically illustrate the magnets 32 of theimpeller and the magnets 32 arranged with respect to the drive unit 4.In this embodiment, four magnets 32 are provided that are separated byrespective gaps 66. The gaps 66, which may be formed as channels betweenthe surfaces 33 of the magnets 32, extend in a radial direction from thecentral opening 36 towards the outer perimeter of the magnets 32. Aswill be described in more detail below with reference to FIGS. 15 a and15 b , the reduction of the size of the magnets 32 does not cause a lossof efficiency of the magnetic coupling. FIG. 13 b illustrates therelative arrangement of the magnets 32 and the drive unit 4, where a gap65 is provided between the drive unit 4 (i.e., the stator) and themagnets 32 of the impeller (i.e., the rotor). The channels or gaps 66improve washing of the gap 65 since they cause a centrifugal pump effectfor the blood.

With reference to FIGS. 14 a and 14 b , the principle of the magneticcoupling between the rotor, in particular the magnets 32, and thestator, i.e., the drive unit 4, is schematically illustrated. In FIG. 14a , the magnets 32 are not or substantially not separated by a gap. Someexemplary magnetic field lines from north N to south S are illustrated.Due to the gap 65 between the drive unit 4 and the magnets 32 theinnermost magnetic field lines do not interact with the drive unit 4.That is to say, this part of the magnetic field does not contribute tothe drive of the impeller. Thus, no efficiency of the magnetic couplingwill be lost if a gap 66 is provided between the magnets 32. In FIG. 14b , the same amount of magnetic field lines reaches the drive unit 4 asin FIG. 14 a . As a skilled person knowing the orientation of magneticfield lines is able to calculate, the size of the gap 66 is directlydependent on the size of the gap 65.

With reference to FIG. 15 , another embodiment of a drive arrangementfor a blood pump is shown. The drive unit 4, including the posts 40 withcoil windings 47, is substantially the same as described above. Likereference numerals refer to like parts. As in the previous embodiments,the drive unit 4 includes a back plate 50. However, the design of theimpeller is different. In FIG. 15 only the magnets 32 and the yoke 37 ofthe impeller are shown. The impeller has an increased diameter, inparticular a larger diameter than the drive unit 4, and an axialextension 39 such that the extension 39 extends circumferentially aboutthe drive unit 4, in particular in the area of the head portions 42 ofthe posts 40. This arrangement allows for improved magnetic coupling, aswill be explained in the following.

As indicated by some exemplary schematic magnetic field lines, theextension 39 causes the magnetic coupling between the magnets 32 and thedrive unit 4 to occur not only in the region of the inclined surfaces 43but also in the region of the outer side surfaces of the head portions42 of the posts 40. In this region the magnetic field lines extend in asubstantially radial direction between the blood pump's rotor and statorand a high torque can be created to drive the impeller. As alsoillustrated in FIG. 15 , as in all other embodiments, the magnetic fieldlines form a closed loop that extends through the posts 40, includingthe head portions 42 and the shaft portions 41, through the magnets 32and through both end plates or yokes 50 and 37.

With reference to FIG. 13 , the operating mode of the drive unit isschematically illustrated in an example having six posts 40 a, 40 b, 40c, 40 d, 40 e and 40 f. In order to create a rotating magnetic field,the posts are controlled sequentially. The posts are controlled in pairsto establish a balanced rotation of the impeller, in which diametricallyopposing posts 40 a and 40 d, 40 b and 40 e, and 40 c and 40 frespectively form pairs. The magnetic density can be increased byactivating four of the six posts at the same time. FIG. 13 illustrates asequence with three steps, in which the activated posts are marked. Inthe first step, the posts 40 a, 40 c, 40 d and 40 f are activated, i.e.,a current is supplied to the respective coil winding to create amagnetic field. In the second step, the posts 40 a, 40 b, 40 d and 40 eare activated, while in the third step, the posts 40 b, 40 c, 40 e and40 f are activated. This sequence is repeated to create the rotatingmagnetic field.

The invention claimed is:
 1. An intravascular blood pump forpercutaneous insertion into a patient's blood vessel, comprising: a pumpcasing having a blood flow inlet and a blood flow outlet, an impellerarranged in the pump casing, the impeller rotatable about an axis ofrotation, and the impeller having blades sized and shaped for conveyingblood from the blood flow inlet to the blood flow outlet, and a driveunit for rotating the impeller, the drive unit comprising a plurality ofposts arranged about the axis of rotation, wherein each of the postsincludes a shaft portion and a head portion, with each of the headportions pointing towards the impeller, wherein a coil winding isdisposed about the shaft portion of each of the posts, each of the coilwindings being sequentially controllable to create a rotating magneticfield, wherein the impeller comprises at least one magnet arranged tointeract with the rotating magnetic field to cause rotation of theimpeller, wherein the head portion of each post has a top surfaceinclined at an angle relative to a plane perpendicular to the axis ofrotation, and wherein the at least one magnet of the impeller has asurface facing the head portions of the posts and being inclined at anangle corresponding to the angle of the inclined surface of at least oneof the head portions.
 2. The intravascular blood pump of claim 1,wherein a distance between the axis of rotation and a center of eachinclined top surface in a radial direction is less than or equal to adistance between the axis of rotation and a center of a cross-sectionalarea of each shaft portion of the respective post in a radial direction.3. The intravascular blood pump of claim 1, wherein at least one of thehead portions is triangular in cross-section along a plane including theaxis of rotation.
 4. The intravascular blood pump of claim 1, whereinthe inclined surfaces of the head portions form a conical surface. 5.The intravascular blood pump of claim 4, wherein the at least one magnetof the impeller defines a conical recess corresponding in size and shapeto the conical surface formed by the head portions of the posts.
 6. Theintravascular blood pump of claim 1, wherein the impeller comprises atleast two magnets.
 7. The intravascular blood pump of claim 1, whereineach of the head portions has a larger cross-sectional dimension thanthe respective shaft portion in a plane perpendicular to the axis ofrotation.
 8. The intravascular blood pump of claim 7, wherein each coilwinding does not extend beyond the head portion of the post about whichit is disposed at least in a radial direction.
 9. The intravascularblood pump of claim 1, wherein the drive unit further comprises a backplate which engages ends of the shaft portions of the posts opposite thehead portions.
 10. The intravascular blood pump of claim 9, wherein theback plate comprises a plurality of apertures arranged about the axis ofrotation and receiving the ends of the shaft portions.
 11. Theintravascular blood pump of claim 9, wherein the back plate includes adiameter in a range of 3 millimeters and 9 millimeters.
 12. Theintravascular blood pump of claim 1, further comprising a housingsurrounding the drive unit.
 13. The intravascular blood pump of claim 1,wherein the drive unit has a central opening extending along the axis ofrotation.
 14. The intravascular blood pump of claim 13, wherein thecentral opening is configured to receive an elongate pin, with an axialend surface of the pin forming a bearing surface for the impeller. 15.The intravascular blood pump of claim 1, wherein the drive unit isdisposed inside the pump casing.
 16. The intravascular blood pump ofclaim 1, wherein the angle is between about 30° and 60°.
 17. Theintravascular blood pump of claim 1, wherein the angle is about 45°. 18.The intravascular blood pump of claim 1, wherein the inclined surfacesface radially outwards.
 19. The intravascular blood pump of claim 1,wherein the impeller comprises at least four magnets.
 20. Theintravascular blood pump of claim 1, wherein the impeller comprises sixmagnets.
 21. The intravascular blood pump of claim 1, wherein theimpeller comprises eight magnets.
 22. The intravascular blood pump ofclaim 21, wherein the magnets are separated by radially extending gaps.23. The intravascular blood pump of claim 1, wherein the drive unitcomprises at least four posts.
 24. The intravascular blood pump of claim1, wherein the drive unit comprises six posts.
 25. The intravascularblood pump of claim 1, wherein the drive unit comprises eight posts. 26.The intravascular blood pump of claim 1, wherein intravascular bloodpump has an outer diameter in a range of 4 millimeters to 10millimeters.
 27. The intravascular blood pump of claim 1, wherein theplurality of posts are arranged about the axis of rotation such that theplurality of posts include a diameter in a range of 3 millimeters and 8millimeters.